Decitabine
Oncology· 54 cited findings· 1 source document
Company: Unknown MAH
What the regulatory reviews say
Decitabine is indicated for pediatric subjects with Acute Myeloid Leukemia (AML). The drug was evaluated in a multicenter, randomized, two-arm, open-label, parallel design study enrolling 25 subjects aged 1 to 16 years.
Efficacy findings include a Complete Remission (CR) rate of 27.3% and 50.0%. The morphologic CR rate was 27.3% and 50.0%. The total remission rate (CR+CRi) was 81.8% and 85.7%. The median time to CR from randomization was 43 days and 37 days. The median time to remission (CR+CRi) was 41 days and 33 days. Median time to neutrophil recovery (ANC ≥1,000/mm3) was 25 days and 18.0 days, while median time to platelet recovery (≥100,000/mm3) was 22 days and 14.5 days.
Notable safety findings include Grade 3-4 serum chemistry values (any) in 45.4% and 21.4% of subjects. Low (Grade 1-4) postbaseline potassium values were observed in 63.6% and 21.4% of subjects, with Grade 3-4 low potassium values in 54.5% and 7.1%. A shift in potassium level from Grade 0-2 at Baseline to Grade 3-4 during treatment occurred in 13.8% and 8.2% of subjects. Tachycardia and sinus tachycardia were reported in 54.5% and 14.3% of subjects.
Key figures — cited to the source page
| Complete Remission (CR) rate | 27.3 | Unknown MAH — Dacogen EMA EPAR variation assessment report (, p.25 |
| Complete Remission (CR) rate | 50.0 | Unknown MAH — Dacogen EMA EPAR variation assessment report (, p.25 |
| total remission rate (CR+CRi) | 81.8 | Unknown MAH — Dacogen EMA EPAR variation assessment report (, p.13 |
| total remission rate (CR+CRi) | 85.7 | Unknown MAH — Dacogen EMA EPAR variation assessment report (, p.13 |
| median time to CR from randomization | 43 | Unknown MAH — Dacogen EMA EPAR variation assessment report (, p.14 |
| Grade 3-4 serum chemistry values (any) | 45.4 | Unknown MAH — Dacogen EMA EPAR variation assessment report (, p.24 |
| Grade 3-4 low potassium values | 54.5 | Unknown MAH — Dacogen EMA EPAR variation assessment report (, p.24 |
| Tachycardia and sinus tachycardia | 54.5 | Unknown MAH — Dacogen EMA EPAR variation assessment report (, p.24 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.